Kansas University DHA Outcome Study (KUDOS) Follow-Up

Completed · Phase 3 · Has a placebo group

Conditions studied: Pregnancy

In brief

This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.

Key facts

Study ID

NCT02487771

Run by

Susan Carlson, PhD

People needed

190

Starts

2008-07-01

Expected to finish

2016-05-01

Last updated by the study team

2018-02-07

Who can join

Age: 16 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound)
• Agree to consume study capsules from enrollment until delivery
• Agree to return to the study center for delivery
• BMI < 40
• No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive)
• Available by telephone

You may not qualify if…

• Less than 16 or greater than 35 years of age
• BMI < 40
• Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive
• Expecting multiple infants
• Diabetes or gestational diabetes at baseline
• Elevated blood pressure due to any cause
• Not planning to return to the study center for delivery
• Gestational age at baseline < 8 weeks or >20 weeks
• Unable or unwilling to agree to consume capsules until delivery
• Unable to provide informed consent in English

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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